Vascular remodeling device

ABSTRACT

A vascular remodeling device is provided. The device includes an anchor portion, sized for deployment in a blood vessel, that is radially expandable from a collapsed state to an expanded state. The device also includes a distal portion that is sized for deployment in a blood vessel. The distal portion is radially expandable from a collapsed state to an expanded state and, in some embodiments, has a distal face that is sufficiently occlusive in the distal-to-proximal direction to perform a therapeutic blocking function at an aneurysm. Some embodiments have an intermediate portion that connects a distal end of the anchor portion and a proximal end of the distal portion, and in some embodiments, the anchor portion and distal portion are able to pivot relative to each other at or near the intermediate portion.

This application claims priority, pursuant to 35 U.S.C. §119, to U.S.Provisional Patent Application No. 61/467,771, filed Mar. 25, 2011,titled VASCULAR REMODELING DEVICE, and to U.S. Provisional PatentApplication No. 61/487,648, filed May 18, 2011, titled VASCULARREMODELING DEVICE, the entire contents of which are incorporated hereinby reference.

FIELD

The present application generally relates to vascular remodeling devicesand to the manner of their positioning in vessels, including theirpositioning at the junction of neurovascular bifurcations having ananeurysm, and the use of such devices to treat an aneurysm.

BACKGROUND

Neurovascular or cerebral aneurysms affect about 5% of the population.Aneurysms may be located, for example, along arterial side walls (e.g.,the aneurysm 10 illustrated in FIG. 1) and at arterial bifurcations(e.g., the aneurysm 20 illustrated in FIG. 2). The direction of fluidflow is generally indicated by the arrows 16, 26. The aneurysms 10, 20each have a fundus 12, 22, a neck 14, 24, and a fundus-to-neck ratio or“neck ratio.” If the neck ratio is greater than 2 to 1 or if the neck14, 24 is less than 4 mm, the aneurysm 10, 20 may be treated withembolization coils alone because the coils will generally constrainthemselves within the aneurysm 10, 20 without herniating into parentvessels. If the neck ratio is less than 2 to 1 or if the neck 14, 24 isgreater than 4 mm, the aneurysms 10, 20 may be difficult to treat withembolization coils alone because the coils may be prone to herniatinginto parent vessels, as illustrated in FIGS. 3A and 3B. Herniation ofcoils may cause arterial occlusion, stroke, and/or death. Compared tothe bifurcation illustrated in FIG. 2, the efferent vessels of thebifurcation may be at substantially different angles, have substantiallydifferent sizes, and/or be a different quantity (e.g., three or more).Compared to the bifurcation illustrated in FIG. 2, the aneurysm 20 ofthe bifurcation may be offset with respect to the junction (e.g., havinga neck substantially open to one efferent vessel), tilted with respectto a plane created by the vessels (e.g., into or out of the page), etc.Each of these would still be accurately characterized as a “bifurcation”herein.

In order to inhibit such herniation, tubular neck remodeling devices,for example Neuroform®, available from Boston Scientific, andEnterprise™, available from Cordis Neurovascular, may be used to keepcoils or other materials within the fundus of the aneurysm and out ofthe vessels. Tubular remodeling devices generally consist of a braidedwire or cut metallic stent or stents covering the neck of the aneurysm.As illustrated in FIG. 4A, tubular remodeling devices 40 are generallyuseful for side wall aneurysms 10. As illustrated in FIGS. 4B and 4C,tubular remodeling devices 42, 44 are generally less useful foraneurysms 20 at bifurcations (e.g., the basilar tip area), for examplebecause positioning/shaping the remodeling devices to preserve bloodflow through the afferent and efferent vessels while also inhibitingherniation of coils 28 out of the aneurysm 20 can be difficult.

SUMMARY

The present disclosure includes, without limitation, the followingembodiments. Various embodiments of the subject technology are describedas numbered clauses (1, 2, 3, etc.) for convenience. These are providedas examples, and do not limit the subject technology or the presentdisclosure. It is noted that any of the dependent clauses may becombined in any combination, and placed into a respective independentclause. The other clauses can be presented in a similar manner.

1. A vascular remodeling device, comprising:

-   -   an anchor portion radially expandable from a collapsed state to        an expanded state in a blood vessel such that, when expanded,        the anchor portion engages a wall of the vessel, the anchor        portion having a longitudinal axis and a first waist comprising        the radially largest region of the anchor portion in the        expanded state;    -   a distal portion radially expandable from a collapsed state to        an expanded state in a blood vessel and having a second waist        comprising the radially largest region of the distal portion in        its expanded state, the distal portion having a distal face        located distal to the second waist; and    -   an intermediate portion that couples a distal end of the anchor        portion and a proximal end of the distal portion at about the        longitudinal axis, the intermediate portion comprising the        radially narrowest region of the device between the first waist        and the second waist, the distal portion being pivotable        radially away from the longitudinal axis about the intermediate        portion.

2. The device of clause 1, wherein the intermediate portion is confinedwithin a radially central region of the device.

3. The device of clause 1, wherein the intermediate portion is radiallynarrower than the first waist and the second waist.

4. The device of clause 1, wherein the distal portion comprises aplurality of distal struts that extend longitudinally and radiallyoutwardly toward the second waist.

5. The device of clause 4, wherein the distal struts extendlongitudinally and radially outwardly from the intermediate portiontoward the second waist, and further extend longitudinally and radiallyinwardly from the second waist toward a radially central region of thedevice.

6. The device of clause 4, wherein the distal struts each have aproximal end and a distal end, and the distal struts are not joined toeach other along their lengths between their proximal and distal ends.

7. The device of clause 4, wherein the distal struts extendlongitudinally and radially inwardly from the second waist to form thedistal face of the distal portion.

8. The device of clause 7, wherein the distal struts forming the distalface of the distal portion have widened portions.

9. The device of clause 8, wherein the widened portions of the distalstruts are wider than a width of distal struts forming a proximal faceof the distal portion, the proximal face located proximal to the secondwaist.

10. The device of clause 8, wherein each of the widened portions of thedistal struts further comprises a first and second ramp, wherein thefirst ramp extends from an edge of its respective strut to an edge ofthe widened portion, and the second ramp extends from the edge of thewidened portion to the edge of the respective strut.

11. The device of clause 4, wherein the distal struts taper inwardly asthey extend proximally from the second waist toward the intermediateportion.

12. The device of clause 4, wherein a proximal end of each distal strutis joined to the intermediate portion.

13. The device of clause 1, wherein the anchor portion comprises aplurality of anchor struts that extend longitudinally and radiallyoutwardly toward the first waist and the distal portion comprises aplurality of distal struts that extend longitudinally and radiallyoutward toward the second waist.

14. The device of clause 1, wherein the anchor portion and distalportion are able to pivot multiaxially relative to each other at or nearthe intermediate portion.

15. The device of clause 1, wherein the anchor portion, intermediateportion, and distal portion are formed from a single sheet or tube ofmaterial.

16. The device of clause 15, wherein the intermediate portion comprisesan uncut portion of the single sheet or tube of material.

17. The device of clause 15, wherein the anchor portion and distalportion are able to pivot multiaxially relative to each other withoutplastic deformation of the intermediate portion.

18. The device of clause 1, wherein the distal face, when positionedadjacent an aneurysm, at least one of (a) supports a therapeuticallyeffective amount and/or density of at least one filling material and/ordevice in the aneurysm, (b) promotes thrombogenesis, and (c) divertsflow from the aneurysm.

19. A vascular remodeling device, comprising:

-   -   an anchor portion sized for deployment in a blood vessel, the        anchor portion radially expandable from a collapsed state to an        expanded state such that, when expanded in a blood vessel, the        anchor portion engages a wall of the vessel, the anchor portion        having a longitudinal axis and a first waist comprising the        radially largest region of the anchor portion when in the        expanded state;    -   a distal portion sized and configured for deployment in a        junction of two or more human blood vessels, the distal portion        radially expandable from a collapsed state to an expanded state        and having a second waist comprising the radially largest region        of the distal portion when in the expanded state, the distal        portion having a distal face, located distal to the second        waist, sized and configured to occlude an aneurysm adjacent the        junction when the second waist is in the junction and the distal        portion is in the expanded state; and    -   an intermediate portion that interconnects a distal end of the        anchor portion and a proximal end of the distal portion, the        intermediate portion being the radially narrowest region of the        device between the first waist and the second waist, the anchor        portion and distal portion being able to pivot relative to each        other at or near the intermediate portion.

20. The device of clause 19, wherein the intermediate portion comprisesa radially central region of the device.

21. The device of clause 19, wherein the intermediate portion isradially narrower than the first waist and the second waist.

22. The device of clause 19, wherein the distal portion comprises aplurality of distal struts that extend radially outward toward thesecond waist.

23. The device of clause 22, wherein the distal struts extend distallyaway and radially outwardly from the intermediate portion toward thesecond waist, and further extend distally away and radially inwardlyfrom the second waist toward a radially central region of the device.

24. The device of clause 22, wherein the distal struts each have aproximal end and a distal end, and the struts are not joined to eachother anywhere along their length between their proximal and distalends.

25. The device of clause 22, wherein the distal struts extend distallyand radially inwardly from the second waist to form the distal face ofthe distal portion.

26. The device of clause 25, wherein the distal struts forming thedistal face of the distal portion have widened portions, the widenedportions configured to increase an occlusiveness of the distal face.

27. The device of clause 22, wherein the struts taper inward as theyextend proximally from the second waist toward the intermediate portion.

28. The device of clause 22, wherein a proximal end of each strut isjoined to the intermediate portion.

29. The device of clause 19, wherein the anchor portion comprises aplurality of anchor struts that extend radially outward toward the firstwaist and the distal portion comprises a plurality of distal struts thatextend radially outward toward the second waist.

30. The device of clause 29, wherein the distal struts are independentof the anchor struts.

31. The device of clause 19, wherein the anchor portion and distalportion are able to pivot multiaxially relative to each other.

32. The device of clause 19, wherein:

-   -   the anchor portion forms a distal face located distal to the        first waist;    -   the distal portion forms a proximal face located proximal to the        second waist;    -   the distal face of the anchor portion tapers radially inward as        it extends distally from the first waist to join the        intermediate portion; and    -   the proximal face of the distal portion tapers radially inward        as it extends proximally from the second waist to join the        intermediate portion.

33. The device of clause 32, wherein the intermediate portion isconfined in a radially central region of the device.

34. The device of clause 32, wherein the intermediate portion isradially narrower than the first waist and the second waist.

35. The device of clause 32, wherein the proximal face of the distalportion comprises a plurality of radially expandable distal struts andthe distal face of the anchor portion comprises a plurality of radiallyexpandable anchor struts.

36. The device of clause 35, wherein the intermediate portion, theanchor struts, and the distal struts are all formed from a single sheetor tube of material.

37. The device of clause 36, wherein the intermediate portion comprisesan uncut portion of the single sheet or tube of material.

38. The device of clause 37, wherein the anchor portion and distalportion are able to pivot multiaxially relative to each other withoutplastic deformation of the intermediate portion.

39. The device of clause 19, wherein the anchor portion, intermediateportion, and distal portion are all formed from a single sheet or tubeof material.

40. The device of clause 19, wherein:

-   -   the anchor portion forms a distal face located distal to the        first waist;    -   the distal portion forms a proximal face located proximal to the        second waist; and    -   both the distal face of the anchor portion and the proximal face        of the distal portion are less occlusive than the distal face of        the distal portion.

41. The device of clause 40, wherein the anchor portion forms a proximalface located proximal to the first waist, and the proximal face of theanchor portion is less occlusive than the distal face of the distalportion.

42. The device of clause 40, wherein the distal face of the anchorportion and the proximal face of the distal portion are configured notto impede blood flow significantly.

43. The device of clause 40, wherein the distal face of the distalportion is sufficiently occlusive in the distal-to-proximal direction toperform a therapeutic blocking function at the aneurysm.

44. The device of clause 19, wherein the distal face, when positionedadjacent the aneurysm, at least one (a) supports a therapeuticallyeffective amount or density of aneurysm-filling materials or devices inan aneurysm, (b) promotes thrombogenesis, and (c) diverts flow.

45. A vascular remodeling device, comprising:

-   -   an anchor portion comprising a plurality of anchor struts        radially expandable from a collapsed state to an expanded state        for engaging a wall of a blood vessel;    -   a distal portion comprising distal struts radially expandable        from a collapsed state to an expanded state for a engaging wall        of a blood vessel, the distal struts forming a distal face; and    -   an intermediate portion that connects a distal end of the anchor        portion and a proximal end of the distal portion, the        intermediate portion being radially narrower than the anchor        portion and the distal portion;    -   wherein at least one of a distal strut and an anchor strut is        configured to flex along its length, allowing the distal portion        to pivot multiaxially about the intermediate portion and        relative to the anchor portion.

46. The device of clause 19, wherein the intermediate portion isradially narrower than the anchor portion and the distal portion.

47. The device of clause 19, wherein the distal struts extendlongitudinally and radially outwardly from the intermediate portion toform a waist of the distal portion and extend distally from the waist toconverge toward each other.

48. The device of clause 21, wherein the distal struts each have aproximal end and a distal end, and the struts are not joined to eachother along their length between their proximal and distal ends.

49. The device of clause 21, wherein the distal struts extendlongitudinally and radially inwardly from the waist to form the distalface of the distal portion.

50. The device of clause 23, wherein the distal struts forming thedistal face of the distal portion have widened portions, the widenedportions configured to increase an occlusiveness of the distal face.

51. The device of clause 24, wherein the widened portions of the distalstruts are wider than a width of distal struts forming a proximal faceof the distal portion, the proximal face located proximal to the secondwaist.

52. The device of clause 24, wherein the widened portions of the distalstruts further comprise a first and second ramp, wherein the first rampextends from an edge of the distal strut to an edge of the widenedportion, and the second ramp extends from the edge of the widenedportion to the edge of the distal strut.

53. The device of clause 21, wherein the distal struts taper inwardly asthey extend proximally from the second waist toward the intermediateportion.

54. The device of clause 19, wherein the anchor portion, intermediateportion, and distal portion are all formed from a single sheet or tubeof material.

55. The device of clause 28, wherein the intermediate portion comprisesan uncut portion of the single sheet or tube of material.

56. The device of clause 29, wherein the anchor portion and distalportion are able to pivot multiaxially relative to each other withoutplastic deformation of the intermediate portion.

57. A method of treating an aneurysm located near a vascular bifurcationformed at a junction of a parent vessel and multiple branch vessels, themethod comprising:

-   -   providing a vascular remodeling device comprising an anchor        portion, a distal portion, and an intermediate portion that        couples the anchor portion to the distal portion;    -   expanding an engagement region of the distal portion into        engagement with a wall of the junction;    -   orienting the distal portion relative to the aneurysm such        that (a) the distal face extends distally from the engagement        region, and tapers radially inwardly, toward the aneurysm,        and (b) a proximal face of the distal portion extends        proximally, and tapers radially inwardly, away from the        aneurysm;    -   tilting, about the intermediate portion, the distal portion        relative to the anchor portion; and    -   expanding an engagement region of the anchor portion into        engagement with the parent vessel to inhibit movement of the        distal portion from the junction.

58. The method of clause 31, further comprising leaving the distalportion in a tilted orientation relative to the anchor portion afterexpanding the engagement region of the distal portion.

59. The method of clause 31, further comprising inhibiting rotation ofthe distal portion with the expanded anchor portion.

60. The method of clause 31, further comprising allowing blood to flowfrom the parent vessel, through the anchor portion and the proximal faceof the distal portion, and into the branch vessels.

61. The method of clause 34, wherein the anchor portion and the proximalface of the distal portion do not significantly inhibit blood flow.

62. The method of clause 31, further comprising supporting at least onefilling material and/or device in the aneurysm with the distal face ofthe distal portion.

63. The method of clause 36, wherein the distal face of the distalportion comprises a plurality of struts, each strut having widenedportions, the widened portions configured to increase an occlusivenessof the distal face.

64. The method of clause 31, further comprising maneuvering the devicearound a bend of a blood vessel, such that the distal portion and theanchor portion pivot relative to each other at or near the intermediateportion.

65. The method of clause 38, wherein the anchor portion comprises agroup of anchor struts and the distal portion comprises a group ofdistal struts, the anchor struts and distal struts configured to flex atthe bend.

66. The method of clause 38, wherein the intermediate portion allows theanchor portion and distal portion to pivot multiaxially relative to eachother without substantial plastic deformation of the intermediateportion.

67. A vascular remodeling device, comprising:

-   -   an anchor portion radially expandable from a collapsed state to        an expanded state such that, when expanded in a blood vessel,        the anchor portion engages a wall of the vessel, the anchor        portion having a first waist comprising the radially largest        region of the anchor portion when in the expanded state;    -   a distal portion radially expandable from a collapsed state to        an expanded state, the distal portion having a longitudinal axis        and a second waist comprising the radially largest region of the        distal portion when in the expanded state, the distal portion        having a distal face located distal to the second waist; and    -   an intermediate portion that couples a distal end of the anchor        portion and a proximal end of the distal portion, the        intermediate portion comprising the radially narrowest region of        the device between the waists of the anchor and distal portions;    -   wherein the distal portion comprises a plurality of        interconnected distal struts that extend distally from the        proximal end of the distal portion such that (a) proximal to the        second waist, the struts each (i) diverge from the longitudinal        axis and (ii) divide into at least two struts; and (b) distal to        the second waist, the struts each (i) merge with an adjacent        strut, and (ii) converge toward the longitudinal axis.

68. The device of clause 67, wherein the interconnected distal strutsare configured to maintain a three dimensional shape of the anchorportion.

69. The device of clause 67, wherein the interconnected distal strutsare configured to prevent the struts from aggregating toward a singleside of the blood vessel.

70. The device of clause 67, wherein the interconnected struts areconfigured to structurally supported each other.

71. The device of clause 67, wherein each strut extends from anorigination junction and is divided into a first and second branch,wherein the first branch is connected to a first adjacent strut and thesecond branch is connected to a second adjacent strut.

72. The device of clause 71, wherein a length of the first branch and alength of the second branch are different.

73. The device of clause 71, wherein a length of the first branch and alength of the second branch are the same.

74. The device of clause 67, wherein at least one strut extendsproximally from the intermediate portion and is divided into a first andsecond branch at or near the waist of the anchor portion, the firstbranch connected to a first adjacent strut and the second branchconnected to a second adjacent strut.

75. The device of clause 74, wherein a length of the first branch and alength of the second branch are different.

76. The device of clause 74, wherein a length of the first branch and alength of the second branch are the same.

77. The device of clause 74, wherein the first and second adjacentstruts extend proximally from the waist of the anchor portion toward aradially central region of the device.

78. The device of clause 67, wherein the distal struts extendlongitudinally and radially inward from the waist of the distal portionto form the distal face of the distal portion.

79. The device of clause 78, wherein the struts forming the distal facehave widened portions with increased cross-sectional widths thatincrease the occlusiveness of the distal face.

80. The device of clause 79, wherein the widened portions of the strutsare each wider than a width of at least one of plurality of strutsforming a distal portion proximal face, proximal to the waist of thedistal portion.

81. The device of clause 79, wherein the widened portions of the strutsfurther comprise a first and second ramp, wherein the first ramp extendsfrom an edge of the strut to an edge of the widened portion, and thesecond ramp extends from the edge of the widened portion to the edge ofthe strut.

82. The device of clause 67, wherein the intermediate portion, theanchor portion, and the distal portion are all formed from a singlesheet or tube of material.

83. The device of clause 67, wherein:

-   -   the anchor portion forms a distal face located distal to the        waist of the anchor portion;    -   the distal portion foi ns a proximal face located proximal to        the waist of the distal portion; and    -   both the distal face of the anchor portion and the proximal face        of the distal portion are less occlusive than the distal face of        the distal portion.

84. The device of clause 83, wherein the anchor portion forms a proximalface located proximal to the waist of the anchor portion, and theproximal face of the anchor portion is less occlusive than the distalface of the distal portion.

85. The device of clause 83, wherein the distal face of the anchorportion and the proximal face of the distal portion are configured suchthat they do not significantly impede blood flow.

86. The device of clause 67, wherein the distal face is configured toperform a therapeutic blocking function at an aneurysm, the functioncomprising at least one of (a) supporting maintenance of atherapeutically effective amount and/or density of at least one fillingmaterial and/or device in the aneurysm, (b) promoting thrombogenesis,and (c) diverting flow from the aneurysm.

87. A vascular remodeling device, comprising:

-   -   an anchor portion sized for deployment in a blood vessel, the        anchor portion having a longitudinal axis and being radially        expandable from a collapsed state to an expanded state, the        anchor portion having a first waist comprising the radially        largest region of the anchor portion when in the expanded state;    -   a distal portion sized and configured for deployment at a        junction of two or more blood vessels;        -   the distal portion being radially expandable from a            collapsed state to an expanded state, the distal portion            comprising a second waist configured to engage a wall of the            junction when the distal portion is in its expanded state,            the second waist comprising the radially largest region of            the distal portion when the distal portion is in its            expanded state;        -   the distal portion comprising distal struts that form a            distal face located distal to the second waist, the distal            face configured to face an aneurysm adjacent the junction            when the second waist engages the wall and the distal            portion is in its expanded state; and    -   an intermediate portion that couples the anchor portion and the        distal portion;    -   wherein the anchor portion comprises a plurality of        interconnected distal struts that extend distally from the        proximal end of the anchor portion such that (a) proximal to the        first waist, the struts each (i) diverge from the longitudinal        axis and (ii) divide into at least two struts; and (b) distal to        the first waist, the struts each (i) merge with an adjacent        strut, and (ii) converge toward the longitudinal axis.

88. The device of clause 87, wherein the distal face is configured toperform a therapeutic blocking function at the aneurysm, the functioncomprising at least one of (a) supporting maintenance of atherapeutically effective amount and/or density of at least one fillingmaterial and/or device in the aneurysm, (b) promoting thrombogenesis,and (c) diverting flow from the aneurysm.

89. The device of clause 87, wherein the interconnected struts areformed by a first plurality of struts extending from a proximal end ofthe anchor portion, and a second plurality of struts extending from thedistal end of the anchor portion, the first and second plurality beinginterconnected at the first waist by a third plurality of sub-struts.

90. The device of clause 89, wherein the number of the first pluralityof struts equals the number of the second plurality of struts.

91. The device of clause 89, wherein the number of the third pluralityof sub-struts is double each of the number of the first plurality ofstruts and the number of the second plurality of struts.

92. The device of clause 87, wherein the interconnected struts areconfigured to maintain a three-dimensional shape of the anchor portion.

93. The device of clause 87, wherein the interconnected struts areconfigured to prevent the struts from moving substantially toward a sideof the blood vessel.

94. The device of clause 87, wherein the interconnected struts areconfigured to support each other structurally.

95. The device of clause 87, wherein each strut has a proximal end, adistal end, and a center portion between the proximal and distal ends,each center portion being connected to adjacent struts.

96. The device of clause 87, wherein each strut extends from anorigination junction and is divided into a first and second branch,wherein the first branch is connected to a first adjacent strut and thesecond branch is connected to a second adjacent strut.

97. The device of clause 96, wherein a length of the first branch and alength of the second branch are different.

98. The device of clause 96, wherein a length of the first branch and alength of the second branch are the same.

99. The device of clause 87, wherein at least one strut extendsproximally from the intermediate portion and is divided into a first andsecond branch at or near the first waist, the first branch connected toa first adjacent strut and the second branch connected to a secondadjacent strut.

100. The device of clause 99, wherein a length of the first branch and alength of the second branch are different.

101. The device of clause 99, wherein a length of the first branch and alength of the second branch are the same.

102. The device of clause 99, wherein the first and second adjacentstruts extend proximally from the first waist toward a radially centralregion of the device.

103. The device of clause 87, wherein the distal portion comprises aplurality of interconnected distal struts, wherein the distal strutsextend longitudinally and radially inward from the second waist to formthe distal face of the distal portion.

104. The device of clause 103, wherein the struts forming the distalface of the distal portion have widened portions, the widened portionsconfigured to increase the occlusiveness of the distal face.

105. The device of clause 104, wherein the widened portions of thestruts are wider than a width of struts forming a proximal face of thedistal portion, the proximal face located proximal of the waist of thedistal portion.

106. The device of clause 104, wherein the widened portions of thestruts further comprise a first and second ramp, wherein the first rampextends from an edge of the strut to an edge of the widened portion, andthe second ramp extends from the edge of the widened portion to the edgeof the strut.

107. The device of clause 87, wherein the intermediate portion, theanchor portion and the distal portion are all formed from a single sheetor tube of material.

108. The device of clause 103, wherein the interconnected distal strutsextend distally, from the proximal end of the distal portion,substantially along a distal portion longitudinal axis; and whereinproximal to the second waist, the struts (i) diverge from thelongitudinal axis and (ii) each divide into at least two struts; andwherein distal to the second waist, the struts (i) merge with anadjacent strut, and (ii) converge toward the longitudinal axis'.

109. The device of clause 103, wherein the interconnected distal strutsare configured to maintain a three dimensional shape of the distalportion.

110. The device of clause 108, wherein the interconnected distal strutsare configured to prevent struts of the distal portion from movingsubstantially towards a side of the human blood vessel.

111. The device of clause 108, wherein the interconnected distal strutsare configured to structurally support each other.

112. The device of clause 108, wherein each distal strut has a proximalend, a distal end, and a center portion between the proximal end anddistal end, each center portion being connected to adjacent distalstruts.

113. The device of clause 87, wherein each distal strut extends from anorigination junction and is divided into a first and second branch,wherein the first branch is connected to a first adjacent distal strutand the second branch is connected to a second adjacent distal strut.

114. The device of clause 113, wherein a length of the first branch anda length of the second branch are different.

115. The device of clause 113, wherein a length of the first branch anda length of the second branch are substantially the same.

116. The device of clause 87, wherein at least one distal strut extendsdistally from the intermediate portion and is divided into a first andsecond branch at or near the second waist, the first branch connected toa first adjacent distal strut and the second branch connected to asecond adjacent distal strut.

117. The device of clause 116, wherein a length of the first branch anda length of the second branch are different.

118. The device of clause 116, wherein a length of the first branch anda length of the second branch are the same.

119. The device of clause 116, wherein the first and second adjacentdistal struts extend distally from the second waist toward a radiallycentral region of the device.

120. The device of clause 87, wherein:

-   -   the anchor portion forms a distal face located distal to the        first waist;    -   the distal portion forms a proximal face located proximal to the        second waist; and    -   both the distal face of the anchor portion and the proximal face        of the distal portion are less occlusive than is the distal face        of the distal portion.

121. The device of clause 120, wherein the anchor portion forms aproximal face located proximal to the first waist, and the proximal faceof the anchor portion is less occlusive than is the distal face of thedistal portion.

122. The device of clause 120, wherein the distal face of the anchorportion and the proximal face of the distal portion are configured notto impede blood flow significantly.

123. The device of clause 120, wherein the distal face of the distalportion is sufficiently occlusive in the distal-to-proximal direction toperform a therapeutic blocking function at the aneurysm.

For purposes of summarizing the invention and the advantages that may beachieved over the prior art, certain objects and advantages of theinvention are described herein. Of course, it is to be understood thatnot necessarily all such objects or advantages need to be achieved inaccordance with any particular embodiment. Thus, for example, thoseskilled in the art will recognize that the invention may be embodied orcarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught or suggested herein without necessarilyachieving other objects or advantages as may be taught or suggestedherein.

All of these embodiments are intended to be within the scope of thisdisclosure. These and other embodiments are presented in the followingdetailed description having reference to the attached figures, thedisclosure not being limited to any particular disclosed embodiment(s).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example embodiment of a side wall aneurysm.

FIG. 2 illustrates an example embodiment of a bifurcation having ananeurysm.

FIG. 3A illustrates an example embodiment of a side wall aneurysm withherniating embolization coils.

FIG. 3B illustrates an example embodiment of a bifurcation having ananeurysm with herniating embolization coils.

FIG. 4A illustrates an example embodiment of a side wall aneurysmtreated with embolization coils and a tubular remodeling device.

FIGS. 4B and 4C illustrates example embodiments of a bifurcation havingan aneurysm treated with embolization coils and tubular remodelingdevices.

FIG. 5 illustrates an example embodiment of a vascular remodelingdevice.

FIG. 6 illustrates a partial end view of the device of FIG. 5, takenalong the direction indicated by the arrows 6-6 in FIG. 5.

FIG. 7 illustrates a partial end view of the device of FIG. 5, takenalong the direction indicated by the arrows 7-7 in FIG. 5.

FIG. 8 illustrates the device of FIG. 5 in an example of a useenvironment in a vascular bifurcation with an aneurysm.

FIG. 9 illustrates the device of FIG. 5 in an example of a useenvironment in a vascular bifurcation with an aneurysm and an angled orcurving parent vessel.

FIG. 10 illustrates a variation of the device of FIG. 5, in which aproximal section of the device forms an extended waist portion.

FIG. 11 illustrates the device of FIG. 10 in an example of a useenvironment in a vascular bifurcation with an aneurysm.

FIG. 12 illustrates an example configuration of a widened portion foruse on struts of the device of FIG. 5 or the device of FIG. 10.

FIG. 13 illustrates a cut pattern for use in making a device similar tothe device of FIG. 5, but with six struts in the distal section thereof.

FIG. 14 is a detail view illustrating the distal section and part of theproximal section of the cut pattern of FIG. 13.

FIG. 15 is a detail view illustrating a proximal end portion of the cutpattern of FIG. 13.

FIG. 16 illustrates a cut pattern for use in making a device similar tothe device of FIG. 5, but with four struts in each of the proximal anddistal sections thereof.

FIG. 17 is a detail view illustrating the distal section and part of theproximal section of the cut pattern of FIG. 16.

FIG. 18 is a detail view illustrating a proximal end portion of the cutpattern of FIG. 16.

FIG. 19 illustrates part of a method of inserting a vascular remodelingdevice into a vascular bifurcation having an aneurysm, and/or oftreating the aneurysm.

FIG. 20 illustrates another part of the method of FIG. 19.

FIG. 21 illustrates another part of the method of FIGS. 19-20.

FIG. 22 illustrates part of a method of placing filling material in ananeurysm located near a bifurcation having a remodeling device therein.

FIG. 23 illustrates another part of the method of FIG. 22.

FIG. 24 illustrates another part of the method of FIGS. 22-23.

FIG. 25 illustrates a cut pattern for use in making another embodimentof the device.

FIG. 26 illustrates a detail view of a proximal section of the cutpattern of FIG. 25.

FIG. 27 illustrates a detail view of a distal section of the cut patternof FIG. 25.

FIG. 28 illustrates a device made with the cut pattern of FIGS. 25-27,in an expanded state.

FIG. 29 illustrates a detail view of the proximal section of the deviceof FIG. 28.

FIG. 30 illustrates a proximal end view of the proximal section of thedevice of FIG. 28.

FIG. 31 illustrates a detail view of the distal section of the device ofFIG. 28.

FIG. 32 illustrates a distal end view of the distal section of thedevice of FIG. 28.

DETAILED DESCRIPTION

Although certain embodiments and examples are described below, it shouldbe appreciated that this disclosure extends beyond the specificallydisclosed embodiments and/or uses and obvious modifications andequivalents thereof. Thus, it is intended that the scope of thisdisclosure should not be limited by any particular embodiments describedbelow.

FIGS. 5-7 illustrate an example embodiment of a vascular remodelingdevice 50. It will be appreciated that the device 50 may be morecompliant than the vasculature in which it is deployed such that it maybe somewhat misshapen after being deployed, and that certain shapesdescribed herein are when the device 50 is an expanded (e.g., furtherexpanded) state with no restriction. The device 50 comprises a proximalsection 52 (or “bottom section” or “proximal portion” or “anchorportion”), an intermediate section 54 (or “middle section” or “junction”or “pivot junction”), and a distal section 56 (or “top section” or“distal portion”). The device 50 can be delivered via a catheter (e.g.,microcatheter) into a bifurcation to support an aneurysm filling devicewith minimal interruption of blood flow in afferent and efferentvessels. In some embodiments, the device 50 may be retrieved and/orrepositioned.

The proximal section 52 can be radially self-expanding and comprise aplurality of radially self-expanding struts 58. Six struts 58 aredepicted in the proximal section 52 of FIGS. 5-6 (and only four of thestruts 58 are visible in FIG. 5), but more or fewer struts may beemployed in the proximal section 52, as described in further detailherein. The struts 58 converge toward the radial center of the proximalsection 52 at the distal end of the proximal section 52, where theproximal section joins the proximal end of the intermediate section 54,and at the proximal end of the proximal section 52, where the proximalsection joins a proximal end portion 60 of the device 50.

The proximal end portion 60, located at the proximal end of the device50, may comprise a simple interconnection of the proximal ends of thestruts 58, or it may comprise a coupling to facilitate delivery and/orre-sheathability and re-positionability of the device 50. Such acoupling may comprise an electolytic, mechanical, chemical and/orinstant detachment mechanism, configured to connect the device 50 to adelivery member such as a pusher wire.

When the device 50 is in the expanded configuration shown in FIGS. 5-7,the proximal struts 58 extend radially outward as they advance from theproximal and distal ends of the proximal section 52, thereby formingproximal and distal tapering portions or faces 62, 64 of the proximalsection 52. The struts 58 reach their radially outermost extent in awaist portion 66 of the proximal section 52, between the proximal anddistal faces 62, 64. When the device 50 is deployed in a patient'svasculature, the waist 66 may engage a vessel wall to hold the proximalsection 52 and device 50 in place as desired. (Depending on the shape ororientation of the vessel, bifurcation, etc., other portions of theproximal section 52 may engage the vessel wall in addition to or insteadof the waist 66.) In the depicted waist portion 66, the struts 58 arecurved and form curving radial crests or peaks. Alternatively, in thewaist 66 the struts 58 can be flat and generally straight and parallel,to form an elongate and/or cylindrical waist 66.

The struts 58 of the proximal section 52 can have a substantiallyrectangular or flat cross section (e.g., where the struts 58 compriseuncut portions of a metallic tube or sheet). The struts 58 canalternatively have a substantially round (e.g., circular, elliptical,ovoid) cross section (e.g., where the struts 58 comprise roundfilaments). The proximal section 52 can comprise two or more struts 58,or between two and twelve struts 58. Although the proximal section 52depicted in FIGS. 5-7 comprises six struts 58, the proximal section canalternatively comprise two, three, four, five, seven, eight, nine, ten,eleven or twelve struts 58. Still other numbers of struts are possible.As seen in FIG. 6, the proximal struts 58 may be equally angularlyspaced and/or oriented around the central longitudinal axis of thedevice 50 (e.g., six struts 60° apart from each adjacent strut as shownin FIG. 6, two struts 180° apart from each other, three struts 120°apart, four struts 90° apart, etc.). Although the arrangement of thestruts are shown in the figures as substantially isometric, thearrangement can place the struts in various angles relative to eachother (e.g., six struts varying about 20°, about 40°, about 50°, about70°, and about 80° apart from each adjacent strut). When the device 50is placed at a bifurcation, the proximal section allows flow to efferentvessels because the struts 58 do not block fluid flow.

The tapered proximal face 62 of the proximal section 52 may allow thedevice 50 or portions thereof (e.g., the proximal section 52) to beretrieved back (e.g., in the proximal direction) into a deliverycatheter via a distal opening thereof. For example, if the device 50 isbeing pulled into a catheter, the tapered proximal face 62 may radiallycompress the proximal section 52. The ability to retrieve the device 50or proximal section 52 facilitates removal or re-positioning of thedevice 50 if an initial placement is not satisfactory.

The distal section 56 can be radially self-expanding and comprise aplurality of radially self-expanding struts 68. Eight struts 68 aredepicted in the distal section 56 of FIGS. 5 and 7 (and only five of thestruts 68 are visible in FIG. 5), but more or fewer struts may beemployed in the distal section 56, as will be described in furtherdetail below. The struts 68 converge toward the radial center of thedistal section 56 at the proximal end of the distal section 56, wherethe distal section joins the distal end of the intermediate section 54,and at the distal end of the distal section 56, where the distal sectionjoins a distal end portion 70 of the device 50.

When the device 50 is in the expanded configuration shown in FIGS. 5-7,the distal struts 68 extend radially outward as they advance from theproximal and distal ends of the distal section 56, thereby formingproximal and distal tapering portions or faces 72, 74 of the distalsection 56. The struts 68 reach their radially outeithost extent in awaist portion 76 of the distal section 56, between the proximal anddistal faces 72, 74. When the device 50 is deployed in a patient'svasculature, the waist 76 may engage a vessel wall to hold the distalsection 56 and device 50 in place as desired. (Depending on the shape ororientation of the vessel, bifurcation, etc., other portions of thedistal section 56 may engage the vessel wall in addition to or insteadof the waist 76.) In the depicted waist portion 76, the struts 68 arecurved and form curving radial crests or peaks. Alternatively, in thewaist 76 the struts 68 can be flat and generally straight and parallel,to form an elongate and/or cylindrical waist 76.

One or more of the struts 68 of the distal section 56 can optionallyinclude or form widened portions or leaves 78 on the distal face 74 ofthe distal section. As best seen in FIG. 7, the widened portions 78 canprovide a blocking function to prevent or reduce the passage ofmaterials or fluids through the distal face 74. For example, in oneaspect, the widened portions may be wider than a width of the strutsforming the proximal face of the distal section.

In another aspect, the widened portions may comprise a first and secondramp, where the first ramp extends from an edge of the strut to an edgeof the widened portion, and the second ramp extends from the edge of thewidened portion to the edge of the strut. In this manner, the widenedportions 78 can help support aneurysm filling materials or devices (suchas coils or embolic materials) within an aneurysm, and/or reduce orblock fluid flow through the distal face 74 to promote thrombogenicityand increase the occlusiveness of the distal face.

Instead of or in addition to the widened portion(s) 78, a mesh, membraneor other covering may be employed on the distal face 74 to performsimilar function(s). Notwithstanding the presence of the widenedportion(s) 78, mesh, membrane or other covering, the distal face 74 caninclude sufficient open space to allow a microcatheter or other similardevice to pass through, to place coils or other aneurysm fillingmaterials or devices in an aneurysm covered by the distal face 74.

The distal section 56 can therefore allow for safe and controlledplacement of coils, and can be designed to support a certain packingdensity of coil. If desired, the widened portion(s) 78, mesh, membraneor other covering can block fluid and material passage through thedistal face 74 of the distal section 56 to a degree sufficient toprovide a flow diversion effect, and serve as a flow diverter, which mayallow omission of any coils or other aneurysm filling materials ordevices.

The struts 68 of the distal section 56 can have a substantiallyrectangular or flat cross section (e.g., where the struts 68 compriseuncut portions of a metallic tube or sheet). The struts 68 canalternatively have a substantially round (e.g., circular, elliptical,ovoid) cross section (e.g., where the struts 68 comprise roundfilaments). A circular, elliptical or ovoid cross-section may beimparted to otherwise square or rectangular struts 58/68 by processingsteps such as electropolishing. The distal section can comprise two ormore struts 68, or between two and twelve struts 68. Although the distalsection 56 depicted in FIGS. 5-7 comprises eight struts 68, the distalsection can alternatively comprise two, three, four, five, six, seven,nine, ten, eleven or twelve struts 68. Still other numbers of struts arepossible. As seen in FIG. 7, the distal struts 68 may be equallyangularly spaced and/or oriented around the central longitudinal axis ofthe device 50 (e.g., eight struts 45° apart from each adjacent strut asshown in FIG. 6, two struts 180° apart from each other, three struts120° apart, four struts 90° apart, etc.). When the device 50 is placedat a bifurcation, the proximal face 72 of the distal section 56 allowsflow to efferent vessels because the struts 68 of the proximal face 72do not block fluid flow.

The tapered proximal face 72 of the distal section 56 may allow thedevice 50 or portions thereof (e.g., the distal section 56) to beretrieved back (e.g., in the proximal direction) into a deliverycatheter via a distal opening thereof. For example, if the device 50 isbeing pulled into a catheter, the tapered proximal face 72 may radiallycompress the distal section 56. The ability to retrieve the device 50 ordistal section 56 facilitates removal or re-positioning of the device 50if an initial placement is not satisfactory.

One or both of the proximal and distal sections 52, 56 can optionally begenerally spherical in shape when in the expanded or deployed state.

The intermediate section 54 connects the proximal section 52 and thedistal section 56, and can be relatively short and relatively narrow(relative to the length and width of the proximal and distal sections52, 56 when they are expanded). The intermediate section 54 can belocated in a radially central region of the device 50, and can beconfined to that radially central region (e.g., the device 50 can lackany interconnection between the proximal and distal sections 52, 56radially outward of the intermediate section 54). So configured, theintermediate section 54 allows the distal section 56 to pivot withrespect to the proximal section and thereby allow the device 50 to bedeployed in tortuous vasculature.

The intermediate section 54 may permit “multiaxial” pivoting or tilting,e.g. at least about a first axis through the intermediate section 54 andorthogonal to the plane of the page in FIGS. 5 and 8-9, and about asecond axis through the intermediate section 54 and orthogonal to thefirst axis. The intermediate section 54 may permit “omniaxial” pivotingor tilting, about the first and second axes described above, and anyradially-oriented axis passing through the intermediate section 54.

The intermediate section 54 may comprise a relatively short uncut tubedefining a generally tubular outer surface and the proximal and distalstruts 58, 68 can comprise proximal and distal extensions of theintermediate section 54 and its tubular outer surface, and be integraland monolithic with the intermediate section 54 and its outer surface.The struts 58, 68 can extend radially outward as they extend proximally(proximal struts 58) and distally (proximal struts 68) from the proximaland distal ends, respectively, of the intermediate portion 54. Theproximal struts 58 and/or the distal struts 68 can be co-cylindricalwith the intermediate portion 54 where they join the intermediateportion 54 at its proximal and distal ends, respectively. Where theyjoin the intermediate portion 54, the proximal struts 58 and/or thedistal struts 68 can be wider (in the circumferential direction withrespect to the tubular form of the intermediate portion) than they arethick, and of similar thickness as the sidewall of the intermediateportion 54.

The device 50 may provide multiaxial or omniaxial pivoting or tilting upto relatively high deflection angles (e.g., up to 90 degrees) withoutsignificantly affecting the ability of the proximal and distal sections52, 56 to maintain their expanded states and engage the adjacentportions of the bifurcation 25 (see FIGS. 8, 9). This capability can befacilitated by making the proximal struts 58 independent of the distalstruts 68, e.g. as depicted in FIGS. 5, 8-11, 13 and 16. The two groupsof struts are independent of each other in that forces acting solely on,and/or deflections occurring solely in, the proximal struts 58 do notsignificantly affect the ability of the distal struts 68 to maintaintheir expanded state and/or maintain engagement with adjacent portionsof the bifurcation 25, and forces acting solely on, and/or deflectionsoccurring solely in, the distal struts 68 do not significantly affectthe ability of the proximal struts 58 to maintain their expanded stateand/or maintain engagement with adjacent portions of the bifurcation 25.

One, some or all of the struts 58 can bend or pivot with respect to theintermediate section 54 independently of one, some or all of the struts68, and vice versa. The intermediate section 54 may promote independenceby interconnecting the struts 58 and the struts 68 in a radially centralregion of the device 50, and physically and functionally separatingthem, absorbing bending stresses from the struts 58 and the struts 68rather than transmitting them from the struts 58 to the struts 68 orvice versa.

Instead of or in addition to independence of the proximal struts 58 as agroup, from the distal struts 68 as a group, the struts 58 may beindependent of each other (within the group of struts 58), and/or thestruts 68 may be independent of each other (within the group of struts68). In the device 50 as depicted in FIGS. 5-9, the proximal struts 58are independent of each other and the distal struts 68 are independentof each other. Each proximal strut 58 can bend or pivot with respect tothe intermediate section 54 independently of the other proximal struts58, and each distal strut 68 can bend or pivot with respect to theintermediate section 54 independently of the other distal struts 68.Independence is promoted within each group of struts 58, 68 byinterconnecting them only at their proximal and distal ends, and in aradially central region of the device 50.

It should be noted, however, that independence as used herein does notexclude interconnecting independent components by members (e.g.membranes, very fine wires and the like) that are insufficiently rigidto cause one component to significantly affect the action of the other.The proximal struts 58 and/or the distal struts 68 can also beindependent of each other, but only within a limited region of theproximal section 52 and/or distal section 58. For example, the proximalstruts 58 may be independent of each other within the distal face 64 ofthe proximal section, and/or the distal struts 68 may be independent ofeach other within the proximal face 72 of the distal section 56.

The tapered distal face 64 of the proximal section 52 and taperedproximal face 72 of the distal section 56 also allow the sections 52, 56to pivot significantly without contact between the sections 52, 56 otherthan at the intermediate section 54.

The intermediate section 54 can be rigid or flexible. Where theintermediate section 54 is rigid, the pivotability of the device 50 canbe provided by the flexibility and/or independence of the struts 58 inthe distal face 64 of the proximal section 52 and of the struts 68 inthe proximal face 72 of the distal section 56. In this example, theproximal and distal sections are able to pivot multiaxially relative toeach other without requiring plastic deformation of the intermediatesection. Each of struts 58 and struts 68 may be capable of flexing,extending, bowing, straightening, bending, or other elastic or plasticdeformation along the length or a portion thereof.

As struts 58 and struts 68 independently flex and extend, sections 52,56 can pivot about intermediate section 54 and relative to each other.For example, struts on one side of a section may flex (e.g., bend), andstruts on an opposing side of a section may extend (e.g., straighten),whereby the section pivots about the region where the struts connect tointermediate section 54.

According to embodiments, such action is facilitated along one or moresections of the device. According to embodiments, this pivot action isprovided without requiring plastic deformation of intermediate section54 or any action along the length of intermediate section 54. Theintermediate section 54 can comprise a short length of hypotube (e.g., ashort length of uncut hypotube when the proximal and/or distal sections52, 56 are cut from the hypotube) which may be flexible or rigid.According to embodiments, the intermediate section 54 can comprise aflexible coil, longitudinally oriented such that its winds spiral aroundthe central longitudinal axis of the device 50, or the intermediatesection 54 can comprise a ball-and-socket joint, a length of flexiblewire, or other flexible member.

The device 50 can further comprise one or more radiopaque markers (e.g.coils) coupled to or wound around portions of the device. For example,the device 50 can include radiopaque markers on one, two or all three ofthe proximal end portion 60, intermediate section 54, and distal endportion 70. Instead of or in addition to those markers, the device 50can include radiopaque markers on one or more of the struts 58, and/oron one or more of the struts 68. According to embodiments, when any ofthe proximal end portion 60, intermediate section 54, or distal endportion 70 defines a central lumen therethrough (e.g., when the device50 is cut or etched from a tube or sheet), radiopaque material may beplaced within some, one or all of those lumens to make the portion(s)60/54/70 radiopaque. For example, radiopaque material maybe providedwithin a lumen of at least one of portion(s) 60/54/70 with securement atone or both of the ends of the lumen.

The device 50 can comprise a self-expanding, super elastic, and/or ashape-memory material (e.g., comprising Nitinol, CoCr alloy, shapememory polymers (e.g., polyglycolic acid, polylactic acid), etc.),thereby causing the device 50 to be self-expanding under certainconditions (e.g., when not restrained by a catheter). In someembodiments, the proximal section 52, the intermediate section 54,and/or the distal section 56 may comprise different materials. Forexample, the distal section 56 may comprise polymer material while theproximal section 52 and the intermediate section 54 comprise metallicmaterial, a different polymer material, etc. For another example, thedistal section 56 may comprise metallic material while the proximalsection 52 and the intermediate section 54 comprise different metallicmaterials, polymer material, etc. Other combinations of materials arealso possible. The device 50 can assume a low profile compressed state(e.g., confined within a catheter) for delivery. When cut from a tube orsheet, the device 50 may assume substantially the diameter of the tubeor rolled sheet when in the compressed state. Upon deployment from thecatheter, the device 50 expands from the compressed state to an expandedstate.

FIG. 8 depicts one example of the device 50 in use, positioned at ajunction 36 of a bifurcation 25 (e.g., a neurovascular bifurcation(e.g., the basilar tip area)) comprising at least one afferent or parentvessel 30, efferent or branch vessels 32, 34, the junction 36 of thevessels 30, 32, 34, and an aneurysm 20 having a fundus 22 and a neck 24.The proximal section 52 is positioned in the parent vessel 30 in anexpanded state, such that the waist 66 contacts the inner wall of thevessel 30. Where the proximal section 52 is self-expanding, the struts58 are biased radially outward and the struts in the waist 66 may engageor “grip” the vessel wall, thereby anchoring the proximal section 52 andthe device 50 in the parent vessel 30. The distal section 56 ispositioned in the junction 36 in an expanded state, such that the waist76 contacts the inner wall of the junction 36. Where the distal section56 is self-expanding, the struts 68 are biased radially outward and thestruts in the waist 76 may engage or “grip” the junction wall, therebyanchoring the distal section 56 and the device 50 in the junction 36.The struts 68 of the distal section 56 may also center the distalsection 56 (and the distal face 74 thereof) in the junction 36 and/oraneurysm neck 24.

When the proximal and distal sections 52, 56 are in their expandedstate, the friction force developed between the proximal section 52 andthe inner wall of the parent vessel 30, and/or the friction forcedeveloped between the distal section 56 and the inner wall of thejunction 36, may suffice to prevent the device 50 from movingsignificantly in the proximal direction, away from the aneurysm 20 andin the distal direction, toward the aneurysm 20.

In the implementation depicted in FIG. 8, the distal face 74 of thedistal section 56 extends into and occupies at least a portion of theneck 24 of the aneurysm 20. The struts 68 and widened portion(s) 78 (oranother structure, such as a mesh or membrane) make the distal face 74sufficiently low in porosity that the face 74 and device 50 can act as ascaffolding to inhibit or prevent herniation or prolapse of objects(e.g., embolization coils or materials, thrombi, etc.) out of the neck24 of the aneurysm 20.

The device 50 can permit blood to flow from the parent vessel 30 to theefferent vessels 32, 34 of the bifurcation. The proximal section 52presents minimal axially-facing or proximally-facing surface area (seeFIG. 6) toward oncoming blood flow in the parent vessel 30 so that bloodpasses through the proximal section 52 with little or no blockage. Theproximal face 72 of the distal section 56 likewise presents minimalaxially-facing or proximally-facing surface area toward blood flow thathas passed through the proximal section 52, so that such blood passesinto or through the distal section 56 with little or no blockage. Inaddition, depending on the manner in which the device 50 is positionedin the bifurcation 25, blood that has passed through the proximalsection 52 may flow around the distal section 56 and into one or bothefferent vessels 32, 34 (indicated by arrow 80 in FIG. 8), instead of orin addition to blood that flows through the distal section 56 and intothe vessel(s) 32, 34.

The depicted distal face 74 of the distal section 56 is configured toimpede or block blood flow therethrough, via the widened portions 78and/or other structures as disclosed elsewhere herein. Accordingly,blood tends to stagnate in and around the distal face 74, promotingthrombogenesis, occlusion of the aneurysm 20, and retention of anyfilling materials and thrombi in the aneurysm.

FIG. 9 depicts another example of the device 50 in use, positioned at ajunction of a bifurcation 25 which is similar to that depicted in FIG.8, with the exception that the parent vessel 30 is significantly angledor curved with respect to the efferent vessels 32, 34, the junction 36,and/or the aneurysm 22. For example, in such a bifurcation the centralaxis of the parent vessel 30 can be non-coaxial and non-parallel with acentral axis of the junction 36 and/or a central axis of the aneurysm20.

As depicted in FIG. 9, the various components of the device 50 performthe same functions in the same manner as described with regard to FIG.8, except that the proximal and distal portions 52, 56 are not coaxial,but are in a tilted orientation (e.g., their respective central axesform an included angle of less than 180 degrees). In addition, one, twoor all three of (a) the intermediate portion 54, (b) the struts 58 ofthe distal face 64 of the proximal portion 52, and (c) the struts 68 ofthe proximal face 72 of the distal portion 56, may flex or pivot toaccommodate the tilted orientation of the portions 52, 56 with respectto each other. In this manner, despite the tortuosity of the bifurcation25, the proximal portion 52 can engage the parent vessel 30 and supportthe distal portion 56 in the junction 36 and neck 24 sufficiently toprevent significant migration of the device 50 in the distal or proximaldirections, and the distal portion 56 can be approximately centeredwithin the junction 36 and neck 24 (and, where appropriately configured,can engage the inner wall of the junction 36 to provide additionalanti-migratory support).

To facilitate tilting/flexing/pivoting in the manner depicted in FIG. 9,the connections of the struts 58 and/or the struts 68 to theintermediate portion 54 may be configured to provide pivoting action,such as by making the struts 58/68 slightly thinner where they meet orconnect to the intermediate portion 54. Such a pivotable arrangement ofthe struts and intermediate portion may allow the portions 52 and 56 totilt with respect to each other without significantly buckling ordeforming the struts and altering the expanded shape of the portions 52,56. In other words, the pivoting connections of the struts 58/68 to theintermediate portion (instead of, or in addition to, a flexibleintermediate portion 54) can relieve some or all of the bending stressimparted to the struts 58/68 when the device 50 takes on a tiltedorientation as in FIG. 9. These structural features may be employedinstead of or in addition to others disclosed herein to promotepivoting/tilting the sections 52, 56 without substantially affectingtheir ability to remain expanded or engage adjacent portions of thebifurcation. The device 50 may be configured to allow the portions 52,56 to tilt/flex/pivot with respect to each other up to 90 degrees.

FIGS. 10-11 depict another example of the device 50, which can besimilar in structure, function, methods of use and construction, etc. tothe device 50 described herein with reference to FIGS. 5-9, except asfurther described herein. Accordingly, like reference numerals refer tolike components in FIGS. 5-9, on the one hand, and FIGS. 10-11 on theother hand, except where a description or depiction to the contrary isprovided expressly herein. In the device 50 of FIGS. 10-11, the waist 66comprises a number of waist members 67 that interconnect both laterally(e.g., circumferentially) and longitudinally. The waist members 67 canthus form a number of bands of diamond forms 69 which are expandable incircumference to engage or grip the inner wall of the parent vessel 30when the device 50 is in use. The waist members 67 can be arranged incircumferentially expandable patterns other than the one depicted inFIGS. 10-11, with or without the use of diamond forms 69.

The struts 58, and the proximal and distal faces 62, 64 of the proximalsection 52, can be similar to those described herein with reference tothe device 50 of FIGS. 5-9. In the device 50 of FIGS. 10-11 the proximalface 62 of the proximal section 52 and the proximal end portion 60 maybe omitted altogether, to create a device 50 with an open proximal end.

In a variation of the device 50 of FIGS. 5-9, or of the device 50 ofFIGS. 10-11, the waist 66 can comprise an expandable woven mesh, wovenfrom filaments of any material disclosed herein as suitable forconstructing the device 50. Such a woven mesh can be cylindrical inform, with the distal edge thereof connected to the proximal ends of thestruts 58 of the distal face 64 of the proximal portion 52. The proximaledge of the cylindrical mesh can be connected to the distal ends of thestruts 58 of the proximal face 62 of the proximal portion 52. Accordingto embodiments, the proximal face 62 of the proximal section 52 and theproximal end portion 60 may be omitted altogether, to create a device 50with an open proximal end.

FIG. 11 depicts one example of the device 50 of FIGS. 10-11 in use,positioned at a junction 36 of a bifurcation 25 in a manner similar tothat depicted in FIG. 8. The proximal section 52 is positioned in theparent vessel 30 in an expanded state, such that the waist 66 contactsthe inner wall of the vessel 30. Where the proximal section 52 isself-expanding, the struts 58 are biased radially outward and the waistmember 67 and diamond forms 69 are biased to a circumferentiallyexpanded state so that the waist 66 engages or “grips” the vessel wall,thereby anchoring the proximal section 52 and the device 50 in theparent vessel 30. Furthermore, the functions, modes of action, andmethods of use of these and the other components of the device 50 ofFIGS. 10-11 are the same as described elsewhere herein (including inconnection with FIGS. 8-9) for the device 50 of FIGS. 5-9.

FIG. 12 depicts one example of a widened portion 78 that may be employedwith any of the embodiments of the device 50 disclosed herein. One, someor all of the widened portions 78 (and struts 68) of the device 50 maytake the form depicted in FIG. 12 and further described herein. To formthe widened portion 78, the strut 68 can be longitudinally split intosub-struts 82 that surround an opening 84 in the widened portion 78. Theopening 84 can be left as an open space, in which case thethrombogenicity of the distal face 74 of the distal section 56 isenhanced by the division of the struts 68 of the distal face into alarger number of narrower, spread-apart sub-struts 82. According toembodiments, the opening 84 can be filled or covered with radiopaquematerial, and/or radiopaque coils can be wound around the sub-struts 82.According to embodiments, a combination of open and covered/filledradiopaque widened portions 78, and sub-struts 82 bearing radiopaquecoils, can be employed. The widened portions may also alternate or varyin size from one strut 68 to the next.

The struts 68 can be configured to form the sub-struts 82 and opening 84via tapering portions 86 on either side of the opening 84. Distal andproximal of the tapering portions 86, the struts 68 can be ofsubstantially uniform width. The proximal portion 88 of the strut 68(proximal of the widened portion 78) can be wider than the distalportion 90 of the strut 68 (distal of the widened portion 78). In such acase, the width of the proximal strut portion 88 can nonetheless besubstantially uniform from the proximal tapering portion 86 to theintermediate portion 54, and the width of the distal strut portion 90can be substantially uniform (but narrower than the width of theproximal strut portion 88) from the distal tapering portion 86 to thedistal tip portion 70 of the device 50. By employing struts 68 that arenarrower in their distal portions 90 than in their proximal portions 88,the distal face of the distal portion 56 can be made relativelycompliant and therefore more easily conformable to any embolic materialin the aneurysm 20, while retaining a desired degree of stiffness in theproximal components of the device 50.

The various versions of the vascular remodeling device 50 disclosedherein (e.g. the devices 50 of FIGS. 5-12) can be manufactured in aprocess comprising cutting (or electrochemically etching) and shaping ametallic tube or sheet (e.g., a laser cut hypotube or sheet). A laser orelectrochemical etcher may cut out portions of the tube, leaving inplace the various structural elements of the proximal section 52, theintermediate section 54, and/or the distal section 56. In the device 50depicted in FIGS. 5-9 and 12, or the device 50 depicted in FIGS. 10-12,the proximal section 52, the intermediate section 54, and the distalsection 56 can be integrally formed from a metallic tube and not cutaway from each other. In devices 50 in which all sections 52, 54, 56 areintegrally fabricated by being cut, etched, etc. from the same tube orsheet, the device 50 is of single-piece construction, taking the form ofa single, partial tube or sheet. Alternatively, the sections 52, 54, 56can be formed separately and then assembled together using any suitabletechnique, such as welding, gluing, interlocking, crimping, swaging,braiding, deposition, etc. Where the intermediate section 54 comprises acoil, the sections 52 and 56 may be formed from the same or separatetubes, and then attached to either end of the coil using any suchsuitable technique.

After cutting from one or more tubes, the device 50 or section(s)52/54/56 thereof may be reshaped and heat treated to impart shapesetting to the device or section(s). The shape setting process mayinclude several steps comprising, for example, stretching and confiningthe cut tube into a new shape during the heat treatment. At the end ofeach heat treatment step, the cut tube assumes the shape in which it wasconfined during the heat treatment process. The final shape (e.g.,expanded state) and size may obtained by several such steps. The device50 or cut tube may be electropolished during manufacture, which canreduce the initial wall thickness of the tube to a final, desiredthickness.

Although the device 50 is depicted in its expanded state in FIGS. 5-11,the device 50 can have a contracted state in which the proximal anddistal sections 52, 56 take on a smaller diameter than in the expandedstate. For example, in the contracted state the sections 52, 56 can havea diameter small enough to fit within a delivery device, such as amicrocatheter. Where the sections 52, 54, 56 are cut from a single tube,the diameter of one or both of the proximal and distal sections 52, 56when in the contracted state can be substantially equal to the diameterof the tube from which the device 50 is cut, and/or substantially equalto the diameter of the intermediate section 54.

The table below provides an example set of dimensions that can beemployed in constructing the device 50 of FIGS. 5-9 and 12. Such adevice 50 can have a proximal section 52 with six struts 58, and adistal section 56 with eight struts 68. The table below also provides anexample set of dimensions for all components of the device 50 of FIGS.10-12 that are common with the device 50 of FIGS. 5-9 and 12. Thedimensions provided below should not be taken as limiting with respectto the device 50 of FIGS. 5-9 and 12 or the device 50 of FIGS. 10-12.One, several or all of these dimensions can be disregarded whenconstructing the device 50 of FIGS. 5-9 and 12 or the device 50 of FIGS.10-12.

Component Dimension Size proximal diameter at waist 66 3-14 mm section52 (expanded) diameter at waist 66 0.015 in., 0.010-0.030 in.(contracted) length (expanded) 10 mm, 2-20 mm or more width of struts 580.0045 in., 0.003-0.006 in. thickness of struts 58 0.0015 in.,0.001-0.004 in. intermediate length 0.15 mm, 0-5 mm section 54 diameter0.015 in., 0.010-0.030 in. wall thickness 0.0015 in., 0.001-0.004 in.distal diameter at waist 76 2-20 mm, 4-15 mm section 56 (expanded)diameter at waist 76 0.015 in., 0.010-0.030 in. (contracted) length(expanded) 2-20 mm, 4-15 mm width of struts 68 0.0035 in. (proximal ofwidened portions 78) 0.003 in. (distal of widened portions 78) thicknessof struts 68 0.0015 in., 0.001-0.004 in. width of sub-struts 82 0.002in., 0.001-0.003 in. thickness of sub-struts 82 0.0015 in., 0.001-0.004in. length of opening 84 2-5 mm width of opening 84 0.5-4 mm

FIGS. 13-15 depict an example of a cut pattern 100 that can be employed(e.g., in laser cutting or etching a hypotube or sheet) to construct thedevice 50 of FIGS. 5-9 and 12. The cut pattern 100 of FIGS. 13-15 issuitable for a device 50 having six struts 68 in the distal portion 56;otherwise, the device 50 formed via the cut pattern 100 can be similarin structure, function and method of use to the device 50 depicted inFIGS. 5-9 and 12 and described elsewhere herein. The cut pattern 100provides uncut areas that form the various components of the device 50.Those components of the device 50 are marked in FIGS. 13-15 with thesame reference numerals as in FIGS. 5-9 and 12 (and, for commoncomponents, as in FIGS. 10-11).

FIGS. 16-18 depict another example of a cut pattern 200 that can beemployed (e.g., in laser cutting or etching a hypotube or sheet) toconstruct the device 50 of FIGS. 5-9 and 12. The cut pattern 200 ofFIGS. 16-18 is suitable for a device 50 having four struts 58 in theproximal portion 52 and four struts 68 in the distal portion 56. The cutpattern 200 also forms widened portions 78 whose longitudinal midpointsare on the waist 66 of the distal portion 56, rather than on the distalface 74 thereof. Otherwise, the device 50 formed via the cut pattern 200can be similar in structure, function and method of use to the device 50depicted in FIGS. 5-9 and 12 and described elsewhere herein. The cutpattern 200 provides uncut areas that form the various components of thedevice 50. Those components of the device 50 are marked in FIGS. 16-18with the same reference numerals as in FIGS. 5-9 and 12 (and, for commoncomponents, as in FIGS. 10-11).

FIGS. 8, 9 and 11 illustrate examples of the placement of the device 50at a bifurcation 25. The proximal section 52 is anchored in the afferentor parent vessel 30, the intermediate section 54 allows perfusion to thebranch or efferent vessels 32, 34, and the distal section 56 acts asscaffolding to inhibit herniation of embolic material from the aneurysm20, and/or to induce thrombogenesis in the aneurysm 20.

Positioning of the device 50 using the parent vessel 30 as the deliverypath for the device 50 may be accomplished via, for example, the methodillustrated in FIGS. 19-21. First, as shown in FIG. 19, a deliverycatheter 300 (e.g., a microcatheter or other catheters that can betracked through and reach the location of the aneurysm 20) is insertedinto the patient's vasculature and advanced distally through the parentvessel 30 until a distal tip 302 of the catheter 300 is placed in thejunction 36, or in the parent vessel 30 proximal of but near thejunction 36, or in the aneurysm 22. The device 50 is then is inserted inthe proximal end of the catheter 300 (or it may be positioned in thecatheter 300 prior to placement of the distal tip 302).

As seen in FIG. 20, the distal section 56 of the device 50 is thenpushed out of the distal end of the catheter 300 (e.g., using a pushwire and pulling the catheter back), allowing the distal section 56 toexpand (e.g., self-expand). While the proximal section 52 remains atleast partially contracted within the catheter 300 as shown in FIG. 20,the position of the expanded distal section 56 relative to the junction36, aneurysm neck 24 and parent vessel 30 can be adjusted viamanipulation of the catheter 300 (and/or push wire, etc.).

One example of a desired placement of the distal section 56 is depictedin FIG. 20, in which the distal face 74 of the distal section 56 spansthe aneurysm neck 24 and/or reduces the effective size of the neck. Suchspanning and/or reduction can involve positioning the distal section 56such that the distal face 74 projects into the neck 24, as depicted inFIG. 20. The placement of the distal section 56 can also involve causingthe expanded waist 76 to engage the inner wall of the junction 36. Suchengagement of the waist 76 (and/or other portions of the distal section56) with the inner wall of the junction 36 can establish and/or maintainboth the longitudinal (proximal-distal) and lateral (transverse to thelongitudinal direction) position of the distal section 56 relative tothe aneurysm neck 24.

To achieve a desired degree of engagement of the distal section 56 withthe junction 36, the presently described method can include deteiminingthe size, width or diameter of the junction 36, and selecting a device50 whose distal section 56 has an unconstrained expanded size, width ordiameter (e.g. at the waist 76 thereof) which is larger than that of thejunction 36. Preferably, the selected distal section 56 is somewhatlarger than the junction 36, for example by about 0.5-1.0 mm.

When the distal section 56 is positioned in the junction 36 as shown inFIG. 20, the inward-tapering, minimally occlusive struts 68 of theproximal face 72 can allow blood to flow with minimal or no obstructionfrom the parent vessel 30 to the branch vessels 32, 34, either throughthe proximal face 72 (arrow 79) or around the proximal face 72 (arrow80). At the same time, the relatively highly occlusive distal face 74can span the neck 24 and/or reduce the effective size of the neck.

The deployment of the device 50 can further proceed with additionalproximal withdrawal of the catheter 300 (and/or distal pushing of thedevice 50) so that the intermediate section 54 emerges from the catheter300, followed by the proximal section 52, which is allowed to expand(e.g. self-expand). In this manner, the waist 66 can engage the innerwall of the parent vessel 30 as shown in FIG. 21, and the proximalsection 52 can secure the position of the device 50, particularlyagainst longitudinal movement. Additionally, the extension of theproximal section 52 into the parent vessel 30 can prevent rotation ofthe distal section 56 in the junction 36 (or, where applicable, the neck24 or aneurysm 20), and help maintain the waist 76 in engagement withthe inner wall of the junction (or neck, or aneurysm).

Where the parent vessel 30 is angled or curved with respect to theefferent vessels 32, 34 or the aneurysm 20 (see, e.g. FIG. 9), thepresently described method can involve tilting, flexing or pivoting thedistal section 56 relative to the proximal section 52 (or vice versa),e.g. as the device 50 is advanced into position, and/or adjusted inposition or orientation once advanced and deployed or partiallydeployed. Where the blood vessel has a bend, the device may be amaneuvered around the bend allowing the distal section and the proximalsection to pivot relative to each other at or near the intermediatesection. The device 50 can be left in its tilted/flexed/pivotedconfiguration following deployment, as depicted in FIG. 9. When thedevice 50 is deployed in such angled or curved vasculature, portions ofthe proximal section 52 other than the waist 66 may engage the innerwall of the parent vessel 30, depending on the degree to which thesections 52, 56 are tilted with respect to each other. For example, theproximal and/or distal faces 62, 64 of the proximal section 52 mayengage the inner wall of the parent vessel 30. The proximal section 52can be tilted within the parent vessel 30 such that one side of theproximal face 62 and the opposite side of the distal face 64 both engagethe inner wall of the vessel. In addition, the intermediate section 54may engage or contact the vessel wall as well.

Where a suitable proximal end portion 60 and deployment apparatus areemployed, the device 50 can be fully retrieved inside the catheter 300,the position of the catheter 300 can be adjusted, and the device 50 canbe redeployed, for example to a more desirable position if the positionof any section 52, 54, 56 after initial deployment of the device 50 wasnot as desired after initial deployment. Additionally or alternatively,the device 50 can be fully retrieved inside the catheter 300 and adifferent catheter or the same catheter 300 with a different device 50(e.g., a device 50 having different dimensions such as diameter of theproximal portion 52, length of the intermediate portion 54, etc.) can bedeployed, for example at a more desirable position or with moredesirable properties (e.g., better anchoring, better neck coverage,etc.). Once the device 50 is positioned, the device 50 can be detachedfrom the catheter 300, pusher wire, etc. electrolytically, mechanically,or chemically, and the catheter 300 withdrawn (see FIG. 21). Thecatheter 300 may then be withdrawn from the bifurcation 25, therebyleaving or permanently positioning the device 50 at the junction 36 ofthe bifurcation 25.

Embolic material may be placed in the aneurysm 20 before, after, and/orduring positioning of the device 50. FIGS. 22-24 depict placement ofembolic material (in particular, embolic coil(s)) after placement of thedevice 50. A catheter, which can comprise the catheter 300 or a separatecatheter 310 as shown in FIG. 22, is advanced distally through theparent vessel 30 and the proximal and distal sections 52, 56 of thedevice 50 until a distal tip 312 thereof passes through and ispositioned distal of the distal section 56, in the fundus 22. As seen inFIG. 23, one or more coils 320 (and/or other aneurysm filling material)can then be advanced distally through the catheter 310 and into thefundus 22. Sufficient coils 320 and/or other material can be sodelivered into the fundus 22 to create a mass 330 of filling material inthe fundus (FIG. 24). The device 50, in particular the distal face 74 ofthe distal section 56, can act as a scaffolding to support the mass 330in the aneurysm 20 and prevent herniation of coils or other materialthrough the neck 24.

FIGS. 25-32 depict a version of the device 50 (and a cut pattern 300 forconstructing it) that can be similar to any of the other versions orembodiments of the device 50 disclosed or summarized herein, instructure, configuration, function, method of manufacture, method ofuse, and material choice, except as further discussed herein. In thedevice 50 of FIGS. 25-32, the struts 58 of the proximal section 52comprise a number (e.g. 6, as depicted, or any other suitable number) ofproximal strut portions 58 a and a corresponding number of distal strutportions 58 b.

The proximal portions 58 a and the distal portions 58 b are rotated orshifted laterally with respect to each other, such that each proximalportion 58 a opposes (e.g., approximately one-half of each of) twodistal portions 58 b, and vice versa. From the distal end of eachproximal portion 58 a, two sub-struts 58 c extend distally to the twodistal portions 58 b that oppose (or are longitudinally adjacent) theproximal portion 58 a from which the sub-struts 58 c extend.Accordingly, each proximal portion 58 a is connected to the two adjacentor opposing distal portions 58 b (and vice versa) via sub-struts 58 c.For example, each strut may have a proximal end, a distal end, and acenter portion therebetween, the center portion connected to adjacentstruts.

In another example, each strut may extend from an origination junctionand be divided into a first and second branch, wherein the first branchis connected to a first adjacent strut and the second branch isconnected to a second adjacent strut. In this example, a length of thefirst branch and a length of the second branch may be different suchthat a connecting point between the strut and the first adjacent strutis disposed at a different longitudinal position than a connecting pointbetween the strut and the second adjacent strut.

According to embodiments, the length of the first branch and the lengthof the second branch may be the same. In another example, at least onestrut may extend proximally from the intermediate section and be dividedinto a first and second branch at or near the waist of the proximalsection. The first branch may be connected to the first adjacent strutand the second branch may be connected to the second adjacent strut. Thefirst and second adjacent struts may extend proximally from the waist ofthe proximal section toward the radially central region of the device.

According to embodiments, one or more sections 52, 56 may have a firstplurality of struts extending from a proximal end of the section and asecond plurality of struts extending from the distal end of the section.The first and second plurality of struts may be interconnected at thewaist or middle portion of the section by a third plurality of struts.Each of the first plurality of struts may be connected to two or more ofthe third plurality of struts. Each of the second plurality of strutsmay be connected to two or more of the third plurality of struts. Thenumber of the first plurality of struts may equal the number of thesecond plurality of struts. The number of the third plurality of strutsmay be double, triple, or another multiple of one or each of the numberof the first plurality of struts and the number of the second pluralityof struts.

When the proximal section 52 of the device 50 of FIGS. 25-32 isexpanded, the sub-struts 58 c extend both longitudinally to interconnectthe proximal end portion 60 and the intermediate section 54, andlaterally or circumferentially to each neighboring proximal or distalportion 58 a or 58 b. The resulting lateral or circumferentialinterconnection of the struts 58 of the proximal section 52 increasesthe outward radial force exerted by the proximal section 52 (and theinward radial force that the proximal section 52 can withstand withoutcollapse) when expanded and thereby improves the ability of the proximalportion 52 to “grip” the vessel wall (e.g. of the parent vessel 30) andprevent migration of the deployed device 50 along the vessel lumen. Inaddition, the lateral/circumferential interconnection of the struts ofthe proximal section 52 reduces the tendency of the expanded struts 58to bunch together in the vessel or “half-moon.” Further, thelateral/circumferential interconnection of the struts of the proximalsection maintains the three dimensional shape of the proximal section.Moreover, the lateral/circumferential interconnection of the struts ofthe proximal section provides structural support for the interconnectedstruts.

As depicted in FIGS. 25-26 and 28-29, the sub-struts 58 c (e.g., thepeaks thereof) can form the waist 66 of the proximal portion 52, orotherwise comprise the radially outermost portion of the proximalportion 52. The sub-struts 58 c can optionally be approximatelylongitudinally centered on the longitudinal midpoint of the proximalportion 52, such that the midpoint approximately evenly divides thesub-struts 58 c in the longitudinal direction. Such an arrangement isalso depicted in FIGS. 25-26 and 28-29.

As depicted in FIGS. 27 and 31-32, the widened portions 78 on the distalface 74 of the distal portion 56 can be formed via thelateral/circumferential interconnection arrangement employed in theproximal section 52 and discussed above. To accomplish this, theproximal strut portions 88 and distal strut portions 90 of the distalstruts 68 are rotated or shifted laterally with respect to each other,such that each proximal portion 88 opposes (e.g., approximately one-halfof each of) two distal portions 90, and vice versa. From the distal endof each proximal portion 88, two sub-struts 82 extend distally to thetwo distal portions 88 that oppose (or are longitudinally adjacent) theproximal portion 88 from which the sub-struts 82 extend. Accordingly,each proximal portion 88 is connected to the two adjacent or opposingdistal portions 90 (and vice versa) via sub-struts 82. For example, atleast one strut may extend distally from the intermediate section and bedivided into a first and second branch at or near the waist of thedistal section. The first branch may be connected to the first adjacentstrut and the second branch may be connected to the second adjacentstrut. The first and second adjacent struts may extend distally from thewaist of the distal section toward the radially central region of thedevice.

When the distal section 56 of the device 50 of FIGS. 25-32 is expanded,the sub-struts 82 extend both longitudinally to interconnect theintermediate section 54 and the distal end portion 70, and laterally orcircumferentially to each neighboring proximal or distal strut portion88 or 90. Thus is formed the widened portions 78 having openings 84, ina configuration that increases the outward radial force exerted by thedistal section 56 and its ability to grip the inner wall of a vessel,e.g. at the junction 36. In addition, the lateral/circumferentialinterconnection of the struts 68 of the distal section 56 reduces thetendency of the expanded struts 68 to bunch together in the vessel or“half-moon.” Further, the lateral/circumferential interconnection of thestruts of the distal section maintains the three dimensional shape ofthe distal section. Moreover, the lateral/circumferentialinterconnection of the struts of the distal section provides structuralsupport for the interconnected struts.

As depicted in FIGS. 25, 27 and 31-32, the widened portions 78 and thesub-struts 82 can be located on the distal face 74 of the distal portion56. The widened portions 78 and sub-struts 82 can optionally be locatedwholly distal of the waist 76 of the distal portion 56. Such anarrangement is also depicted in FIGS. 25-26 and 28-29. In other aspects,the widened portions may resemble the structures as disclosed elsewhereherein.

The device 50 of FIGS. 25-32 can be employed in performing any of themethods disclosed herein, e.g. any of the disclosed methods for treatinganeurysms or blood vessels such as those depicted and described withreference to FIG. 8-9 or 19-24. The device 50 of FIGS. 25-32 can bedeployed in vasculature, e.g. at a bifurcation, in the manner depictedin FIG. 8, 9 or 19-24. The features, components, materials or propertiesof the device 50 of FIGS. 25-32 can be combined with any of thefeatures, components, materials or properties of any of the otherversions or embodiments of the device 50 depicted, described orsummarized herein. The configuration of one or both of the proximal anddistal sections 52, 56 of the device 50 of FIGS. 25-32 can be employedwhen constructing the proximal and/or distal sections of any of theother versions or embodiments of the device 50 depicted, described orsummarized herein.

Instead of or in addition to the placement of the mass 330 in theaneurysm 20, the device 50 can be configured as a flow diverter bymaking the distal face 74 of the distal section 56 sufficientlyocclusive to inhibit blood flow out of the fundus 22 and promoteformation of thrombus therein.

In methods in which embolic material was previously inserted in ananeurysm but has herniated, the device 50 can be used as a “rescuedevice” to push the herniated material back into the aneurysm and to actas a scaffolding to inhibit or prevent further herniation or prolapse ofthe embolic material. In certain such methods, deployment of the device50 may advantageously avoid traversal of the junction comprising theherniated material by wires or a catheter, which may cause the herniatedmaterial to become tangled and/or dislodged and which may cause ruptureof the aneurysm.

Although invention(s) have been disclosed herein in the context ofcertain embodiments and examples, it will be understood by those skilledin the art that the invention(s) extend beyond the specificallydisclosed embodiments to other alternative embodiments and/or uses ofthe invention(s) and obvious modifications and equivalents thereof. Inaddition, while several variations of the embodiments of theinvention(s) have been shown and described in detail, othermodifications, which are within the scope of this disclosure, will bereadily apparent to those of skill in the art based upon the presentspecification and drawings. It is also contemplated that variouscombinations or sub-combinations of the specific features and aspects ofthe embodiments and examples may be made and still fall within the scopeof the present disclosure. It should be understood that various featuresand aspects of the disclosed embodiments/examples can be combined with,or substituted for, one another in order to form varying modes of theembodiments/examples of the disclosed invention(s). Thus, it is intendedthat the scope of the invention(s) herein disclosed should not belimited by the particular embodiments/examples described above.

1. A vascular remodeling device, comprising: an anchor portion radiallyexpandable from a collapsed state to an expanded state in a blood vesselsuch that, when expanded, the anchor portion engages a wall of thevessel, the anchor portion having a longitudinal axis and a first waistcomprising the radially largest region of the anchor portion in theexpanded state; a distal portion radially expandable from a collapsedstate to an expanded state in a blood vessel and having a second waistcomprising the radially largest region of the distal portion in itsexpanded state, the distal portion having a distal face located distalto the second waist; and an intermediate portion that couples a distalend of the anchor portion and a proximal end of the distal portion atabout the longitudinal axis, the intermediate portion comprising theradially narrowest region of the device between the first waist and thesecond waist, the distal portion being pivotable radially away from thelongitudinal axis about the intermediate portion.
 2. The device of claim1, wherein the intermediate portion is confined within a radiallycentral region of the device.
 3. The device of claim 1, wherein theintermediate portion is radially narrower than the first waist and thesecond waist.
 4. The device of claim 1, wherein the distal portioncomprises a plurality of distal struts that extend longitudinally andradially outwardly toward the second waist.
 5. The device of claim 4,wherein the distal struts extend longitudinally and radially outwardlyfrom the intermediate portion toward the second waist, and furtherextend longitudinally and radially inwardly from the second waist towarda radially central region of the device.
 6. The device of claim 4,wherein the distal struts each have a proximal end and a distal end, andthe distal struts are not joined to each other along their lengthsbetween their proximal and distal ends.
 7. The device of claim 4,wherein the distal struts extend longitudinally and radially inwardlyfrom the second waist to form the distal face of the distal portion. 8.The device of claim 7, wherein the distal struts forming the distal faceof the distal portion have widened portions.
 9. The device of claim 8,wherein the widened portions of the distal struts are wider than a widthof distal struts forming a proximal face of the distal portion, theproximal face located proximal to the second waist.
 10. The device ofclaim 8, wherein each of the widened portions of the distal strutsfurther comprises a first and second ramp, wherein the first rampextends from an edge of its respective strut to an edge of the widenedportion, and the second ramp extends from the edge of the widenedportion to the edge of the respective strut.
 11. The device of claim 4,wherein the distal struts taper inwardly as they extend proximally fromthe second waist toward the intermediate portion.
 12. The device ofclaim 4, wherein a proximal end of each distal strut is joined to theintermediate portion.
 13. The device of claim 1, wherein the anchorportion comprises a plurality of anchor struts that extendlongitudinally and radially outwardly toward the first waist and thedistal portion comprises a plurality of distal struts that extendlongitudinally and radially outward toward the second waist.
 14. Thedevice of claim 1, wherein the anchor portion and distal portion areable to pivot multiaxially relative to each other at or near theintermediate portion.
 15. The device of claim 1, wherein the anchorportion, intermediate portion, and distal portion are formed from asingle sheet or tube of material.
 16. The device of claim 15, whereinthe intermediate portion comprises an uncut portion of the single sheetor tube of material.
 17. The device of claim 15, wherein the anchorportion and distal portion are able to pivot multiaxially relative toeach other without plastic deformation of the intermediate portion. 18.The device of claim 1, wherein the distal face, when positioned adjacentan aneurysm, at least one of (a) supports a therapeutically effectiveamount and/or density of at least one filling material and/or device inthe aneurysm, (b) promotes thrombogenesis, and (c) diverts flow from theaneurysm.
 19. A vascular remodeling device, comprising: an anchorportion comprising a plurality of anchor struts radially expandable froma collapsed state to an expanded state for engaging a wall of a bloodvessel; a distal portion comprising distal struts radially expandablefrom a collapsed state to an expanded state for a engaging wall of ablood vessel, the distal struts forming a distal face; and anintermediate portion that connects a distal end of the anchor portionand a proximal end of the distal portion, the intermediate portion beingradially narrower than the anchor portion and the distal portion;wherein at least one of a distal strut and an anchor strut is configuredto flex along its length, allowing the distal portion to pivotmultiaxially about the intermediate portion and relative to the anchorportion.
 20. The device of claim 19, wherein the intermediate portion isradially narrower than the anchor portion and the distal portion. 21.The device of claim 19, wherein the distal struts extend longitudinallyand radially outwardly from the intermediate portion to form a waist ofthe distal portion and extend distally from the waist to converge towardeach other.
 22. The device of claim 21, wherein the distal struts eachhave a proximal end and a distal end, and the struts are not joined toeach other along their length between their proximal and distal ends.23. The device of claim 21, wherein the distal struts extendlongitudinally and radially inwardly from the waist to form the distalface of the distal portion.
 24. The device of claim 23, wherein thedistal struts forming the distal face of the distal portion have widenedportions, the widened portions configured to increase an occlusivenessof the distal face.
 25. The device of claim 24, wherein the widenedportions of the distal struts are wider than a width of distal strutsforming a proximal face of the distal portion, the proximal face locatedproximal to the second waist.
 26. The device of claim 24, wherein thewidened portions of the distal struts further comprise a first andsecond ramp, wherein the first ramp extends from an edge of the distalstrut to an edge of the widened portion, and the second ramp extendsfrom the edge of the widened portion to the edge of the distal strut.27. The device of claim 21, wherein the distal struts taper inwardly asthey extend proximally from the second waist toward the intermediateportion.
 28. The device of claim 19, wherein the anchor portion,intermediate portion, and distal portion are all formed from a singlesheet or tube of material.
 29. The device of claim 28, wherein theintermediate portion comprises an uncut portion of the single sheet ortube of material.
 30. The device of claim 29, wherein the anchor portionand distal portion are able to pivot multiaxially relative to each otherwithout plastic deformation of the intermediate portion.
 31. A method oftreating an aneurysm located near a vascular bifurcation formed at ajunction of a parent vessel and multiple branch vessels, the methodcomprising: providing a vascular remodeling device comprising an anchorportion, a distal portion, and an intermediate portion that couples theanchor portion to the distal portion; expanding an engagement region ofthe distal portion into engagement with a wall of the junction;orienting the distal portion relative to the aneurysm such that (a) thedistal face extends distally from the engagement region, and tapersradially inwardly, toward the aneurysm, and (b) a proximal face of thedistal portion extends proximally, and tapers radially inwardly, awayfrom the aneurysm; tilting, about the intermediate portion, the distalportion relative to the anchor portion; and expanding an engagementregion of the anchor portion into engagement with the parent vessel toinhibit movement of the distal portion from the junction.
 32. The methodof claim 31, further comprising leaving the distal portion in a tiltedorientation relative to the anchor portion after expanding theengagement region of the distal portion.
 33. The method of claim 31,further comprising inhibiting rotation of the distal portion with theexpanded anchor portion.
 34. The method of claim 31, further comprisingallowing blood to flow from the parent vessel, through the anchorportion and the proximal face of the distal portion, and into the branchvessels.
 35. The method of claim 34, wherein the anchor portion and theproximal face of the distal portion do not significantly inhibit bloodflow.
 36. The method of claim 31, further comprising supporting at leastone filling material and/or device in the aneurysm with the distal faceof the distal portion.
 37. The method of claim 36, wherein the distalface of the distal portion comprises a plurality of struts, each struthaving widened portions, the widened portions configured to increase anocclusiveness of the distal face.
 38. The method of claim 31, furthercomprising maneuvering the device around a bend of a blood vessel, suchthat the distal portion and the anchor portion pivot relative to eachother at or near the intermediate portion.
 39. The method of claim 38,wherein the anchor portion comprises a group of anchor struts and thedistal portion comprises a group of distal struts, the anchor struts anddistal struts configured to flex at the bend.
 40. The method of claim38, wherein the intermediate portion allows the anchor portion anddistal portion to pivot multiaxially relative to each other withoutsubstantial plastic deformation of the intermediate portion.